Negara: Armenia
Bahasa: Inggris
Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
poliovirus types 1, poliovirus types 3
GlaxoSmithKline Biologicals s.a.
J07BF04
poliovirus types 1, poliovirus types 3
not less than-106CCID50/dose+ not less than-105.8CCID50/dose
suspension oral
(100) glass vials 1ml (10dose)
Prescription
Registered
2016-07-20
DESCRIPTION _Polio Sabin ™O_ _lle_ _ami_ _Three_ _(oral),_ oral suspension Bivalent Oral Poliomyelitis vaccine Types 1 and 3 (bOPY) _Po/~o Sabin ™OJ/e and Three (oral)_ is a bivalent, live attenuated poliomyelitis virus vaccine of the Sabin strains Type I (lSc, 2ab) and Type 3 (Leon 12a, ] b), propagated in MRC5 human diploid cells. Each dose (0.1 1111) contains not less than 10 6 . 0 CCTDso of Type 1 and 10 5 . 8 CCIDso of Type 3. Excipients: Magnesium chloride, L-arginine, polysorbate 80 and water for injections. Neomycin sulphate. polymyxin B sulphate and phenol red are present as residuals from the manufacturing process. ADMINlSTRATION _Polio Sabin_ _TMOl1e_ _and Three (oral)_ is for oral use only (see also sections _Immunization_ _Schedule_ and _Precautions )._ One dose of vaccine (0.1 ml) is contained in two drops which are delivered from the polyethylene dropper supplied with the multi dose container. The vaccine may be administered alone or mixed with beverages or foods provided that these do not contain substances that may inactivate polioviruses, such as preservatives. Suitable vehicles are simple syrup, milk, bread and a lump of sugar. Since the vaccine has a bitter salty taste, it may be given in syrup or on a lump of sugar, particularly when it is to be given to young children. The vaccine should be administered to breast-fed infants, preferably two hours before or after breast-feeding in order to avoid contact with the antibodies present in the breast milk. Care should be taken not to contaminate a multidose dropper with saliva of the vaccinee. The vaccine is presented as a clear liquid, yellowish to pink suspension. Due to minor variation of its pH, _Polio Sabin_ _™_ _One and Three (oral)_ may vary in colour from yellow to pink. Changes of the colour of the vaccine within this range do not signify deterioration of the vaccine. Vaccines should be inspected visually for any particulate matter prior to administration. Multidose vials of _Polio Sabin_ _T1"OIlC_ _and Three (oral)_ from which one o Baca dokumen lengkapnya
_A2_ SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Polio Sabin One and Three (oral), drinkable suspension, rnultidose. Bivalent poliomyelitis vaccine Types I and 3 (Jive, attenuated). 2. QUALIT ATlVE AND QUANTITATIVE COMPOSITION Each dose (0.1 ml) contains: Polio virus type 1 (LSe, 2ab strain) live attenuated" Polio virus type 3 (Leon, 12a, Ib strain) live attenuated" not less than 106.0 _CCIDso_ not less than _lOs.~_ CCIDso *produced on a eulture of human diploid cells The vaccine is presented in a multidose pack. See section 6.5 for the number of doses per vial. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL .FORM Drinkable suspension. Clear, yellowish to pink suspension for oral administration. 4. CLINICAL PARTICULARS 4.1. Therapeutic indications Polio Sabin One and Three (oral) is indicated for active immunisation at any age against poliomyelitis infection caused by poliomyelitis viruses Types I and 3. 4.2. Posology and method of administration Posology In a multi dose vial, one immunising dose consists of two drops. 111e vaccination schedule must be ill accordance with official recommendations. Method of administration Polio Sabin One and Three (oral) is presented ready for use and is for oral administration only. V 15'06'2015 _FA.MHP_ [Documencs A2, B2, C2, _D2,_ E2, F2 and G2 are translations of Documents AI, Bl, cr. Dl, E I and FI. Translations certified by the translator, Shirley Yvonne Barrett] Date: . ~. _10._ _.(,l:t21S·_ _,'._ _'._ _._ _...._ _~.~_ _~_ _'O;J;_ Page 1 of1 82 The vaccine can b~ administered alone or together with beverages or foods (syrup, milk, bread, a sugar IUl~p), pr~V1ded that th~se do not contain substances that may inactivate the virus such as preservatl:es. Since the ~a~cl~e has a slightly bitter, salty taste, it can be given in syrup or on a sugar lump, particularly when It IS given to young children. In breast-fed infants, the vaccine should be administered preferably two hours before or after breast- feeding ill order to avoid any Baca dokumen lengkapnya